The field of bioprocessing and biologics manufacturing is driven by the pursuit of developing safe, effective, and consistent therapies. One of the critical aspects of achieving these goals is implementing robust quality control measures and leveraging advanced analytics throughout the manufacturing process. At the highly anticipated International Bioprocessing and Biologics Forum, a distinguished speaker will present on the captivating topic of "Quality Control and Analytics in Bioprocessing." The event is scheduled to take place on 28th - 29th November, 2023, at the prestigious Steigenberger Airport Hotel in Berlin, Germany.
Quality control serves as a cornerstone in biologics manufacturing, ensuring that the final product meets the required standards of safety, efficacy, and consistency. This presentation will explore the latest advancements in quality control strategies and analytical techniques, showcasing how they play a crucial role in maintaining product quality throughout the manufacturing process.
The speaker will discuss the implementation of quality control measures from the early stages of bioprocess development, including raw material characterization, process development, and optimization. They will highlight the importance of comprehensive process understanding, risk assessment, and robust control strategies to ensure consistent product quality.
The presentation will delve into the various analytical techniques used in bioprocessing, such as high-performance liquid chromatography (HPLC), mass spectrometry, and molecular biology assays. The speaker will discuss the role of these techniques in monitoring critical quality attributes (CQAs) and process parameters, facilitating real-time process control, and ensuring product safety and efficacy.
Moreover, the speaker will explore the application of advanced analytics, including data modeling, multivariate analysis, and artificial intelligence, in quality control. These techniques enable the extraction of valuable insights from complex datasets, leading to improved process understanding, enhanced process robustness, and efficient root cause analysis during investigations.
The presentation will also address the regulatory considerations in quality control and analytics. The speaker will discuss the evolving regulatory landscape, including guidelines from regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). They will highlight the importance of implementing quality-by-design (QbD) principles and risk-based approaches to ensure compliance and facilitate successful regulatory submissions.
Furthermore, the presentation will touch upon the future trends and emerging technologies in quality control and analytics. It will explore topics such as real-time monitoring, process analytical technology (PAT), and the integration of quality control with process development and continuous manufacturing.
In conclusion, the presentation on "Quality Control and Analytics in Bioprocessing" at the International Bioprocessing and Biologics Forum will provide attendees with a comprehensive understanding of the vital role that quality control and analytics play in biologics manufacturing. By highlighting the latest advancements, analytical techniques, regulatory considerations, and future trends, participants will gain valuable insights to enhance their quality control strategies and ensure the production of safe, effective, and consistent biologic therapies. This presentation promises to empower professionals in their pursuit of excellence in bioprocessing and contribute to the continuous improvement of the industry.
To register or learn more about the Forum please check here: https://bit.ly/3zxguXW
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